GalaSHAPE 3D 100042-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00855920006201), received between Mar 26, 2021 and Aug 2, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 2, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2019, PATIENT UNDERWENT BILATERAL CENTRAL MOUND MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. CONCOMITANT PROCEDURES INCLUDED BRACHIOPLASTY, ABDOMINOPLASTY. ON (B)(6) 2020, INFECTION; ONE BREAST WAS REPORTED. PATIENT TREATED WITH MEDICATION. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2020. NO ADDITIONAL INFORMATION GIVEN. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED INFECTION IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Unspecified Infection

  MAUDE report 15144999 ↗
• InjuryJul 28, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(6): ON (B)(6) 2020, PATIENT WAS HOSPITALIZED AND UNDERWENT BILATERAL PRIMARY RECONSTRUCTION; PRE PECTORAL. THE INCISION TYPE WAS NOT RECORDED. MULTIPLE PIECES OF GALAFLEX MESH WERE IMPLANTED DURING THIS PROCEDURE. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2020, RIGHT BREAST WOUND DEHISCENCE WAS REPORTED. ON (B)(6) 2020, PATIENT HAD WASHOUT AND DEBRIDEMENT PROCEDURE AND WAS ALSO TREATED WITH MEDICATION (CEPHALEXIN). IT WAS NOTED THAT THERE WAS NO EVIDENCE OF EXPOSED MESH OR BREAST IMPLANTS. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2020. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED WOUND DEHISCENCE IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Wound Dehiscence

  MAUDE report 15123660 ↗
• InjuryMar 26, 2021Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN REPORTED TO MANUFACTURER'S REPRESENTATIVE THAT HE HAD A PATIENT THAT HAD SURGERY ON (B)(6) 2019 FOR A BREAST LIFT WITH GALAFLEX MESH. ADDITIONAL PROCEDURES INCLUDED ABDOMINOPLASTY AS WELL AS BRACHIOPLASTY. THE MESH WAS USED AS AN OVERLAY OVER THE CENTRAL BREAST MOUND AND AROUND THE AREOLA. EVERYTHING WAS PROGRESSING COMPLETELY NORMALLY UNTIL (B)(6) 2019 WHEN THE PATIENT DEVELOPED THE ABSCESS OVER THE RIGHT BREAST REQUIRING DRAINAGE AFTER FAILURE TO RESPOND TO ANTIBIOTICS. SHE APPEARED TO HAVE RESOLVED WITH INCISION AND DRAINAGE AS WELL AS DOXYCYCLINE AND THE ISSUE WAS IN THE PROCESS OF RESOLUTION. HOWEVER, ON A RECENT FOLLOW-UP EXAMINATION, THE PATIENT WAS PRESENTING WITH DEVICE EXTRUSION SO THE SURGEON DECIDED TO REMOVE PORTIONS OF THE DEVICE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 11577338 ↗